OncoMatch/Clinical Trials/NCT03509961
The EndRAD Trial: Eliminating Total Body Irradiation (TBI) for NGS-MRD Negative Children, Adolescents, and Young Adults With B-ALL
Is NCT03509961 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Myeloablative allogeneic HCT with a non-TBI conditioning regimen for b-cell acute lymphoblastic leukemia.
Treatment: Myeloablative allogeneic HCT with a non-TBI conditioning regimen — This study will evaluate the use of non- TBI (total body irradiation) conditioning for B-ALL patients with low risk of relapse as defined by absence of NGS-MRD (next generation sequencing minimal residual disease) before receiving a hematopoietic cell transplant (HCT). Patients diagnosed with B-ALL who are candidates for HCT will be screened by NGS-MRD on a test of bone marrow done before the HCT. Subjects who are pre-HCT NGS-MRD negative will be eligible to receive a non-TBI conditioning regimen as part of the treatment cohort of the study. Subjects who are pre-HCT NGS-MRD positive will be treated as per treating center standard and will be followed in an observational cohort (HCT center standard of care).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage CR1, CR2, CR3
Demographics
Prior therapy
Must have received: blinatumomab (blinatumomab) — CR1 or CR2
Patients in CR1 or CR2 after blinatumomab treatment.
Must have received: CAR-T cell therapy — CR1 or CR2
Patients in CR1 or CR2 after CAR-T cellular therapy.
Cannot have received: inotuzumab ozogamicin (inotuzumab ozogamicin)
Exception: allowed for observational arm only
Patients who have received inotuzumab treatment prior to allogeneic HCT are NOT eligible for the study treatment arm. All inotuzumab-treated patients are eligible for the observational arm.
Cannot have received: allogeneic hematopoietic stem cell transplant
No prior allogeneic hematopoietic stem cell transplant.
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender.
Liver function
SGOT (AST) or SGPT (ALT) < 5 x ULN for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care.
Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as: Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. Renal: Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender. Cardiac: Shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA), choice of test according to local standard of care. Hepatic: SGOT (AST) or SGPT (ALT) < 5 x upper limit of normal (ULN) for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's of Alabama/University of Alabama in Birmingham(UAB) · Birmingham, Alabama
- Phoenix Children's Hospital · Phoenix, Arizona
- City of Hope · Duarte, California
- Children's Hospital Los Angeles · Los Angeles, California
- UCLA Mattel Children's Hospital · Los Angeles, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03509961 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior inotuzumab ozogamicin, allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.
What disease stage is eligible?
Stage CR1 or CR2 or CR3 is required.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages